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September 1, 2015

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FDA Medical Device Registries Task Force

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FDA Medical Device Registries Task Force

imageThe FDA Center for Devices and Radiographic Health has issued a request for Public Comment in the August 24 Federal Register in regard to a report entitled  “Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge the Clinical Care and Research” developed by the Medical Device Epidemiology Network’s Medical Device Registry Task Force.

The FDA, working under a cooperative agreement with Duke University, convened the Medical Device Registry Task Force as a part of the Medical Device Epidemiology Network public-private partnership in 2014. The Task Force membership includes representatives from stakeholder groups representing patients, providers, hospitals, health plans, industry, government agencies and academic researchers.

The Task Force was asked to develop a strategy to improve the current system for monitoring medical device safety and effectiveness by promoting the development of national and international device registries. This would be accomplished by building on existing data source systems, such as registries and electronic health records to establish “Coordinated Registry Networks” (CRN).

For effective CRN, both Unique Device Identifier (UDI) and patient identification must be achieved across the entire device life cycle, from point of manufacture through end of patient life. Sufficient device and clinical outcome data must be available in near real-time and must be inexpensive and not burdensome to justify any data quality sacrifices made compared to direct data collection.

AAOS attended the August 24th National Medical Device Registries Task Force meeting hosted by the FDA and the American College of Cardiology where the announcement regarding the new National Medical Device Registry Task Force report was announced. During the presentations, Julia Skapik, MD, MPH Medical Officer for the Office of the National Coordinator announced that ONC does not think they will be able to meet the MACRA and MIPS Goals of Implementation, and plans to submit a report to Congress explaining why they are unable to meet the congressionally required goals.